Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394498
Status:
UNKNOWN
Last Update Posted:
2006-11-01
First Post:
2006-10-30
Brief Title:
Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Stem Cell Mobilization by G-CSF by Granulocyte Colony Stimulating Factor Post Myocardial Infarction to Promote Myocyte Repair
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Eighty-six patients with heart attacks will be identified at our hospital Post heart attack we will assess heart function blood flow to the heart and heart cell function We will assess these parameters using nuclear cardiology scans that are used in everyday cardiology practice The patients will then be divided into 2 groups One group will receive a medication called G-CSF and the other group will receive a placebo We will give this drug 1-2ml for 4 days beneath the skin We will take the patients blood during this time and measure how the drug affected their blood The patients will all have the nuclear cardiology tests again in 6 weeks and 6 months to see how their heart is functioning As well they will have a six month angiogram All the patients will otherwise receive optimal care from their Cardiologist They will be seen at 6 12 24 and 52 weeks to assess them clinically
This study will test the effects of G-CSF on the heart function of patients who have had a heart attack It is a medication that that has been shown in an animal model to improve heart function after a heart attack It is a medication that has been used for many years to treat patients with cancers and to increase the number of cells donated by healthy bone marrow donors It has no serious side effects It works by increasing the number of a persons own stem cells in the blood Stem cells are special cells that are present in our bodies that have the ability to form new cells It had been thought that the heart could not make new cells after it has been damaged Other investigators have shown that this might not be the case It is now thought that after an injury stem cells from the bone marrow can transform into cells of the injured tissue Therefore we are trying to increase the number of stem cells in the circulation with G-CSF so as to increase repair in the heart after it has been damaged This strategy has never been tried in human beings and if successful could greatly reduce death and suffering from heart disease
This study will test the effects of G-CSF on the heart function of patients who have had a heart attack It is a medication that that has been shown in an animal model to improve heart function after a heart attack It is a medication that has been used for many years to treat patients with cancers and to increase the number of cells donated by healthy bone marrow donors It has no serious side effects It works by increasing the number of a persons own stem cells in the blood Stem cells are special cells that are present in our bodies that have the ability to form new cells It had been thought that the heart could not make new cells after it has been damaged Other investigators have shown that this might not be the case It is now thought that after an injury stem cells from the bone marrow can transform into cells of the injured tissue Therefore we are trying to increase the number of stem cells in the circulation with G-CSF so as to increase repair in the heart after it has been damaged This strategy has never been tried in human beings and if successful could greatly reduce death and suffering from heart disease
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None